A study on the efficacy of artificial bone filling for osteonecrosis of the femoral head

Not yet recruiting

• Conditions: Osteonecrosis of the femoral head

• Registration Number: jRCT1022250003

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients diagnosed with femoral head necrosis at our hospital

1. Patients diagnosed with femoral head necrosis at Tohoku University Hospital
2. Patients who meet the following criteria according to the Ministry of Health, Labor and Welfare specific disease Idiopathic Femoral Head Necrosis Research Group: Stage 1, 2, 3A, 3B / Type B, C1, C2
3. Age 18 years or older (at time of registration)
4. Gender not important
5. Individuals who have given written consent to participate in the study
6. Surgery is possible within 18 months from the date of first diagnosis of femoral head necrosis by X-ray and MRI.

Exclusion Criteria

1. Patients who have previously undergone surgery around the target hip joint
2. Pregnant or potentially pregnant patients, or breastfeeding patients
3. Patients with tumors, tumor-like diseases, epiphyseal dysplasia, trauma (femoral neck fracture, traumatic hip dislocation, etc.), slipped capital femoral epiphysis, pelvic radiation, femoral head necrosis associated with decompression sickness, or Perthes disease
4. Patients in whom bone drilling is considered difficult due to the location of the necrotic area or the shape of the proximal femur
5. Allergy patients with a history of anaphylaxis, severe allergy patients, or patients known to have allergies to other gelatin, calcium phosphate.
6. Patients who are otherwise deemed inappropriate for participation in this study by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: factorial assignment

Primary Outcome Measures

Name	Time	Method
Presence or absence of progression of femoral head necrosis from baseline to one year later	one year later	Femoral head necrosis was considered to have progressed if any of the following events were observed: 1) Progression in the stage classification of the Ministry of Health, Labor and Welfare's Idiopathic Femoral Head Necrosis Research Group, a specific disease; 2) Performance of total hip arthroplasty (THA).

Secondary Outcome Measures

Name	Time	Method
Length of collapse	Before 3, 6, and 12 months after surgery	Measure the length of collapse using plain X-ray images taken before 3, 6, and 12 months after surgery, and evaluate using the stage classification.
Changes in collapse length (mm)	Before surgery and 3, 6, 12 months after surgery	Changes in the collapse length (mm) using plain X-ray images before surgery and 3, 6, 12 months after surgery.
Improvement of clinical scores	3 months and 1 year after surgery	Compare whether HHS and JHEQ have improved 3 months and 1 year after surgery compared to before surgery
Artificial bone transformation into bone	Before and after surgery	Evaluate whether the artificial bone has been transformed into bone using plain X-ray images taken before and after surgery.